Apologies in advance if I turn out to be hopelessly wrong but I honestly think it's a question of how good the results are perceived to me. I haven't even considered failure as an option.
Further apologies for being ridiculously simplistic but I just keep coming back to the below from the last trial.
Higher dose (70mg/kg body weight vs 200 mg this time) exceeded the pre-specified criteria for improvement in core efficacy measures compared with placebo.
Both doses showed trends of increasing effect with duration of treatment (significantly longer treatment this time)
I know the age factor may play a part but I really truly believe tomorrow is going to prove to be a game changer. I will rest easy tonight.
GLTAH and especially the parents and sufferers.
FDA meeting is today, page-35
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